Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index
|ClinicalTrials.gov Identifier: NCT01165437|
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : February 24, 2011
Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement has been applied to leg pressure measurement and determination of the ankle-brachial index with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity.
In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived from the lower extremities as compared to Doppler-based measurements of blood pressure. We used signal processing analysis and regression techniques to develop a two-step algorithm which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure across the spectrum of peripheral artery disease severity.
This proposed project will validate this novel oscillometric ABI algorithm in a population of patients who have been identified as at risk for PAD and for whom screening ABI has been recommended by multiple professional organizations (AHA/ACC and American Diabetes Association). Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial index and toe-brachial index will be calculated.
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Device: Blood Pressure Measurement|
|Study Type :||Observational|
|Estimated Enrollment :||161 participants|
|Official Title:||Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Suspected Arterial Disease
Patients with known or suspected arterial disease and patients screened using AHA/ACC criteria for P.A.D.
Device: Blood Pressure Measurement
Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165437
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|